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Persons with Diabetes (PWDs), at minimum of (n=120) will successfully collect their urine and test with two Ascensia strip products. The products are: Ketostix and Keto-Diastix.
Persons with Diabetes (PWDs), at minimum of (n=120) will successfully collect their urine and test with two Ascensia strip products.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Testing of Ketostix by Persons with Diabetes. | Each PWD will test Ketostix in their self-collected urine, complete a labeling evaluation, and test four urine control solutions. |
| |
| Testing of Keto-Diastix by Persons with Diabetes. | Each PWD will test Keto-Diastix in their self-collected urine, complete a labeling evaluation, and test four urine control solutions. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Testing of self collected urine | Device | Each PWD will test their self-collected urine. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Testing of self collected urine | Number of Participants with results from self collected urine that are within one color block of reference analyzer | Day 1 |
| Labeling evaluation | Number of Participants with Responses that are a 3,4, or 5 on a 5 point Likert Scale. | Day 1 |
| Testing of Urine controls | Number of Participants with Reponses that read within one color block. | Day 1 |
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Inclusion Criteria:
Exclusion Criteria:
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Person with Diabetes.
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| Name | Affiliation | Role |
|---|---|---|
| Robert H Christenson, PhD | University of Maryland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Maryland | Baltimore | Maryland | 21201 | United States |
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| Labeling Evaluation | Device | Each PWD will complete a labeling evaluation. |
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| Urine Control testing | Device | Each PWD will test four urine control solutions. |
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